BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES

    MDR report key: 13417218 · Received February 1, 2022

    Report

    Report Number
    1917413-2022-00037
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 6, 2022
    Report Date
    April 5, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678414
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO CLOTTING WERE OBSERVED. 5 PRODUCTION LOT IN-HOUSE RETENTION SAMPLES FROM EACH LOT AFFECTED WERE VISUALLY INSPECTED WITH NO ISSUES BEING IDENTIFIED AND SUBMITTED TO THE CHEMISTRY LAB FOR TESTING. ALL RESULTS WERE WITHIN THE SPECIFICATION LIMITS OF 2.67MG ¿ 4.84MG FOR CATALOG 367841. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CLOTTING) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. LABORATORY ANALYSIS OF RETAIN AND CONTROL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. ALL EDTA TUBES PERFORMED AS EXPECTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE CLOTTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1014077. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2021-01-14. MEDICAL DEVICE LOT #: 1040927. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2021-02-09. MEDICAL DEVICE LOT #: 1167580. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. DEVICE MANUFACTURE DATE: 2021-06-16. MEDICAL DEVICE LOT #: 1228046. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. DEVICE MANUFACTURE DATE: 2021-08-16. MEDICAL DEVICE LOT #: 1014077. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2021-01-14. MEDICAL DEVICE LOT #: 1040927. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2021-02-09. MEDICAL DEVICE LOT #: 1167580. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. DEVICE MANUFACTURE DATE: 2021-06-16. MEDICAL DEVICE LOT #: 1228046. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. DEVICE MANUFACTURE DATE: 2021-08-16. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1014077. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2021-01-14. MEDICAL DEVICE LOT #: 1040927. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2021-02-09. MEDICAL DEVICE LOT #: 1167580. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. DEVICE MANUFACTURE DATE: 2021-06-16. MEDICAL DEVICE LOT #: 1228046. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. DEVICE MANUFACTURE DATE: 2021-08-16. MEDICAL DEVICE LOT #: 1014077. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2021-01-14. MEDICAL DEVICE LOT #: 1040927. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2021-02-09. MEDICAL DEVICE LOT #: 1167580. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. DEVICE MANUFACTURE DATE: 2021-06-16. MEDICAL DEVICE LOT #: 1228046. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. DEVICE MANUFACTURE DATE: 2021-08-16. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED CLOTTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: 2ML K2EDTA BLOOD COLLECTION TUBES WERE CLOTTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED CLOTTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: 2ML K2EDTA BLOOD COLLECTION TUBES WERE CLOTTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED CLOTTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: 2ML K2EDTA BLOOD COLLECTION TUBES WERE CLOTTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497846 BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367841 SEE H.10. 50382903678414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown